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CLOVERS Trial- Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis

Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis (CLOVERS) Trial: 

The Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis (CLOVERS) trial aimed to compare the impact of an early restrictive fluid strategy (with early vasopressor use) versus a liberal fluid strategy on 90-day mortality in patients with sepsis-induced hypotension. 

Background: 

In sepsis management, intravenous fluids are administered to improve organ perfusion, but they carry risks such as dilutional coagulopathy and organ dysfunction. Vasopressors are also used, but their use comes with potential complications. Prior observational data suggested that a restrictive fluid strategy with early vasopressor use might be superior. The CLOVERS trial aimed to provide further insights into this matter. 

Design: 

The trial was a multicenter, randomized, unblinded superiority trial conducted as part of the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Patients were randomly assigned to either the restrictive fluid strategy or the liberal fluid strategy. The trial protocol was followed for 24 hours, with protocol adherence monitored. Results: The trial enrolled 1563 patients, with 782 in the restrictive fluid group and 781 in the liberal fluid group. The trial was stopped for futility at the second interim analysis due to the lack of differences in primary and secondary outcomes. There was no significant difference in 90-day mortality between the two groups. The secondary outcomes also did not show any statistically significant differences. Safety outcomes were similar between the groups, with a few cases of potential vasopressor extravasation. The trial supported the use of peripheral IVs for vasopressor administration. 



Limitations: 

The study's population had a relatively low initial illness severity, which may limit generalizability to sicker patient populations. The trial duration was limited to 24 hours, and longer treatment periods might yield different results. The trial was unblinded, which may have influenced the reporting of adverse events. 

The CLOVERS trial did not demonstrate a significant difference in 90-day mortality between restrictive and liberal fluid resuscitation approaches in sepsis-induced hypotension. This supports recent findings from the CLASSIC trial. 

Either strategy may be equally safe for similar patient populations. Tailoring intravenous fluid and vasopressor treatment to individual patients using dynamic measures of fluid responsiveness is important in sepsis resuscitation.

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